BR112015008623A2 - preparation and formulation comprising a mek inhibitor - Google Patents

preparation and formulation comprising a mek inhibitor

Info

Publication number
BR112015008623A2
BR112015008623A2 BR112015008623A BR112015008623A BR112015008623A2 BR 112015008623 A2 BR112015008623 A2 BR 112015008623A2 BR 112015008623 A BR112015008623 A BR 112015008623A BR 112015008623 A BR112015008623 A BR 112015008623A BR 112015008623 A2 BR112015008623 A2 BR 112015008623A2
Authority
BR
Brazil
Prior art keywords
preparation
formulation
mek inhibitor
fluorophenylamino
benzoimidazole
Prior art date
Application number
BR112015008623A
Other languages
Portuguese (pt)
Other versions
BR112015008623B1 (en
Inventor
Max Krell Christoph
Andreas Niederer Daniel
Zimmermann Daniel
Misun Marian
Wolf Marie-Christine
Nichols Paul
J Stengel Peter
Liu Weidong
Heinz Pachinger Werner
Original Assignee
Array Biopharma Inc
Novartis Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50488781&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112015008623(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Array Biopharma Inc, Novartis Ag filed Critical Array Biopharma Inc
Publication of BR112015008623A2 publication Critical patent/BR112015008623A2/en
Publication of BR112015008623B1 publication Critical patent/BR112015008623B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D235/00—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings
    • C07D235/02—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings condensed with carbocyclic rings or ring systems
    • C07D235/04—Benzimidazoles; Hydrogenated benzimidazoles
    • C07D235/06—Benzimidazoles; Hydrogenated benzimidazoles with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached in position 2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D235/00—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings
    • C07D235/02—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings condensed with carbocyclic rings or ring systems
    • C07D235/04—Benzimidazoles; Hydrogenated benzimidazoles
    • C07D235/06—Benzimidazoles; Hydrogenated benzimidazoles with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached in position 2
    • C07D235/08—Radicals containing only hydrogen and carbon atoms
    • C—CHEMISTRY; METALLURGY
    • C30—CRYSTAL GROWTH
    • C30B—SINGLE-CRYSTAL GROWTH; UNIDIRECTIONAL SOLIDIFICATION OF EUTECTIC MATERIAL OR UNIDIRECTIONAL DEMIXING OF EUTECTOID MATERIAL; REFINING BY ZONE-MELTING OF MATERIAL; PRODUCTION OF A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; SINGLE CRYSTALS OR HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; AFTER-TREATMENT OF SINGLE CRYSTALS OR A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; APPARATUS THEREFOR
    • C30B29/00—Single crystals or homogeneous polycrystalline material with defined structure characterised by the material or by their shape
    • C30B29/54—Organic compounds
    • C—CHEMISTRY; METALLURGY
    • C30—CRYSTAL GROWTH
    • C30B—SINGLE-CRYSTAL GROWTH; UNIDIRECTIONAL SOLIDIFICATION OF EUTECTIC MATERIAL OR UNIDIRECTIONAL DEMIXING OF EUTECTOID MATERIAL; REFINING BY ZONE-MELTING OF MATERIAL; PRODUCTION OF A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; SINGLE CRYSTALS OR HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; AFTER-TREATMENT OF SINGLE CRYSTALS OR A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; APPARATUS THEREFOR
    • C30B7/00—Single-crystal growth from solutions using solvents which are liquid at normal temperature, e.g. aqueous solutions
    • C30B7/08—Single-crystal growth from solutions using solvents which are liquid at normal temperature, e.g. aqueous solutions by cooling of the solution
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Metallurgy (AREA)
  • Materials Engineering (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

resumo "preparação e formulação compreendendo um inibidor de mek". a presente invenção refere-se a processos para a preparação de (2-hidroxietióxi)-amida do ácido 6-(4-bromo-2-fluorfenilamino)-7-flúor-3-metil-3h-benzoimidazol-5-carboxílico e processos para a preparação de (2-hidroxietióxi)-amida do ácido 6-(4-bromo-2-fluorfenilamino)-7-flúor-3-metil-3h-benzoimidazol-5-carboxílico cristalizado e intermediários úteis para os mesmos. também aqui são fornecidas composições farmacêuticas que compreendem este composto cristalizado. 1/1summary "preparation and formulation comprising a mek inhibitor". The present invention relates to processes for the preparation of 6- (4-bromo-2-fluorophenylamino) -7-fluoro-3-methyl-3h-benzoimidazole-5-carboxylic acid (2-hydroxyethyloxy) -amide and processes for the preparation of crystallized 6- (4-bromo-2-fluorophenylamino) -7-fluoro-3-methyl-3h-benzoimidazole-5-carboxylic acid (2-hydroxyethyl) -amide and useful intermediates therefor. Also provided herein are pharmaceutical compositions comprising this crystallized compound. 1/1

BR112015008623-3A 2012-10-19 2013-10-18 PROCESSES FOR THE PREPARATION OF CRYSTALIZED 6-(4-BROMO-2-FLUORPHENYLAMINO)-7-FLUORINE-3-METHYL-3H-BENZOIMIDAZOLE-5-CARBOXYL ACID AMIDE AND ITS INTERMEDIATES BR112015008623B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261716169P 2012-10-19 2012-10-19
US61/716,169 2012-10-19
PCT/US2013/065633 WO2014063024A1 (en) 2012-10-19 2013-10-18 Preparation of and formulation comprising a mek inhibitor

Publications (2)

Publication Number Publication Date
BR112015008623A2 true BR112015008623A2 (en) 2017-07-04
BR112015008623B1 BR112015008623B1 (en) 2022-10-25

Family

ID=50488781

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015008623-3A BR112015008623B1 (en) 2012-10-19 2013-10-18 PROCESSES FOR THE PREPARATION OF CRYSTALIZED 6-(4-BROMO-2-FLUORPHENYLAMINO)-7-FLUORINE-3-METHYL-3H-BENZOIMIDAZOLE-5-CARBOXYL ACID AMIDE AND ITS INTERMEDIATES

Country Status (23)

Country Link
US (7) US9238627B2 (en)
EP (3) EP4306171A3 (en)
JP (3) JP6385939B2 (en)
CN (3) CN104870427B (en)
AR (1) AR099630A1 (en)
BR (1) BR112015008623B1 (en)
CA (2) CA2888474C (en)
CY (1) CY1122670T1 (en)
DK (2) DK3702351T3 (en)
ES (1) ES2772498T3 (en)
FI (1) FI3702351T3 (en)
HK (1) HK1214254A1 (en)
HR (1) HRP20240033T1 (en)
HU (1) HUE047708T2 (en)
JO (1) JOP20130304B1 (en)
LT (1) LT3702351T (en)
PL (2) PL3702351T3 (en)
PT (2) PT2909182T (en)
RS (1) RS65117B1 (en)
RU (2) RU2018127873A (en)
SI (2) SI3702351T1 (en)
TW (1) TWI650316B (en)
WO (1) WO2014063024A1 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LT3702351T (en) * 2012-10-19 2024-01-10 Array Biopharma, Inc. Formulation comprising a mek inhibitor
CN105566225A (en) * 2015-02-16 2016-05-11 苏州晶云药物科技有限公司 Crystal forms of orally-taken mitogen-activated protein kinase inhibitor and preparation method of crystal forms
PT3463345T (en) 2016-06-03 2023-01-06 Array Biopharma Inc Pharmaceutical combinations
US20230192625A1 (en) * 2017-11-14 2023-06-22 Shenzhen Targetrx, Inc. Substituted benzimidazole compound and composition comprising same
TW201938165A (en) 2017-12-18 2019-10-01 美商輝瑞股份有限公司 Methods and combination therapy to treat cancer
US11395823B2 (en) * 2018-01-09 2022-07-26 Duke University Topical administration of MEK inhibiting agents for the treatment of skin disorders
WO2020212832A1 (en) * 2019-04-16 2020-10-22 Alembic Pharmaceuticals Limited Process of preparation of benzimidazole compounds
WO2021116901A1 (en) * 2019-12-09 2021-06-17 Biocon Limited Forms of binimetinib and process for preparation thereof
WO2022074011A1 (en) 2020-10-05 2022-04-14 Pierre Fabre Medicament Combination of encorafenib and binimetinib as adjuvant treatment for resected stage ii melanoma
CN112679438A (en) * 2020-12-31 2021-04-20 武汉九州钰民医药科技有限公司 Process for the preparation of semetinib
WO2023084489A1 (en) 2021-11-15 2023-05-19 Pfizer Inc. Methods of treating coronavirus disease 2019
WO2024003942A1 (en) * 2022-07-01 2024-01-04 Natco Pharma Limited An improved process for the preparation of selumetinib sulfate

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KR20020002370A (en) * 1999-01-13 2002-01-09 로즈 암스트롱, 크리스틴 에이. 트러트웨인 Benzoheterocycles and Their Use as MEK Inhibitors
AU6068600A (en) * 1999-07-16 2001-02-05 Warner-Lambert Company Method for treating chronic pain using mek inhibitors
CN101486682B (en) * 2002-03-13 2013-08-14 阵列生物制药公司 N3 alkylated benzimidazole derivatives as MEK inhibitors
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LT3702351T (en) 2012-10-19 2024-01-10 Array Biopharma, Inc. Formulation comprising a mek inhibitor

Also Published As

Publication number Publication date
RU2018127873A (en) 2019-03-14
US10398683B2 (en) 2019-09-03
EP3702351B1 (en) 2023-11-22
ES2772498T3 (en) 2020-07-07
RU2669391C2 (en) 2018-10-11
DK3702351T3 (en) 2024-01-29
AR099630A1 (en) 2016-08-10
PT2909182T (en) 2020-03-02
JP2018135399A (en) 2018-08-30
WO2014063024A1 (en) 2014-04-24
EP2909182A4 (en) 2016-07-06
US20160168104A1 (en) 2016-06-16
US20160168103A1 (en) 2016-06-16
CA2888474C (en) 2021-03-02
JP2016503391A (en) 2016-02-04
TWI650316B (en) 2019-02-11
HK1214254A1 (en) 2016-07-22
EP2909182B1 (en) 2019-12-04
US9598376B2 (en) 2017-03-21
US9382212B1 (en) 2016-07-05
US20140128442A1 (en) 2014-05-08
HRP20240033T1 (en) 2024-03-29
DK2909182T3 (en) 2020-02-17
EP4306171A2 (en) 2024-01-17
BR112015008623B1 (en) 2022-10-25
EP4306171A3 (en) 2024-04-03
TW201427956A (en) 2014-07-16
PT3702351T (en) 2024-01-17
US9562016B2 (en) 2017-02-07
US20180296533A1 (en) 2018-10-18
CA3079071C (en) 2022-06-07
CN109336824A (en) 2019-02-15
JOP20130304B1 (en) 2021-08-17
US9980944B2 (en) 2018-05-29
US20200171002A1 (en) 2020-06-04
CN109336824B (en) 2022-11-11
CA3079071A1 (en) 2014-04-24
US20170231963A1 (en) 2017-08-17
CY1122670T1 (en) 2021-03-12
SI2909182T1 (en) 2020-03-31
EP2909182A1 (en) 2015-08-26
CA2888474A1 (en) 2014-04-24
FI3702351T3 (en) 2024-01-24
RS65117B1 (en) 2024-02-29
US9238627B2 (en) 2016-01-19
JP2019194272A (en) 2019-11-07
CN109456272A (en) 2019-03-12
JP6385939B2 (en) 2018-09-05
CN104870427B (en) 2018-10-23
PL2909182T3 (en) 2020-06-01
PL3702351T3 (en) 2024-04-02
SI3702351T1 (en) 2024-03-29
EP3702351A1 (en) 2020-09-02
RU2015118572A (en) 2016-12-20
US10729678B2 (en) 2020-08-04
US20160168102A1 (en) 2016-06-16
JP6737838B2 (en) 2020-08-12
LT3702351T (en) 2024-01-10
CN104870427A (en) 2015-08-26
HUE047708T2 (en) 2020-05-28

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
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